Conservative Treatment of Ingrown Toenail

Ingrown Nail Clinical Trial

— TOCON  

Official title:

Conservative Treatment of Ingrown Toenail in Stages I or IIa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214586
• Other study ID #: TOCON
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: May 30, 2022

Study information

• Verified date: May 2022
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ingrown toenail has become one of the most prevalent onychopathies and a frequent reason for consultation in podiatry clinics. In the initial stages of the pathology, conservative treatments are the first choice of therapy. The aim was therefore, to analyze and compare the efficacy of the technique of nail re-education with gauze bandage and nail remodelling for the conservative treatment of onychocryptosis in stage I and IIA, A prospective, longitudinal, randomised clinical trial-type analytical study is proposed. A sample of 20 subjects with stage I and IIA onychocryptosis will be selected. Of these, 10 cases were part of the gauze bandage nail re-education group and the remaining 10 cases were part of the nail remodelling group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ingrown toenail in stage I or IIa (Mozena Classification)

Exclusion Criteria:

• Patients not allowed for clinical follow-up of the evolution of the pathology.

• Patients presented with deforming pathologies

• Pattens had been surgically operated for ingrown toenail

Related Conditions & MeSH terms

• Ingrown Nail
• Nails, Ingrown

Intervention

Procedure:
• Follow up of the clinical stage
Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured

Locations

Country	Name	City	State
Spain	Alfonso Martínez Nova	Plasencia	Cáceres

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Extremadura	University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of the disease	Recurrence is defined as a return of the previous symptoms, regrowth of the nail edge, or patient dissatisfaction with the clinical outcome.	3 months
Secondary	Reported pain	Visual analogue scale of pain (0-10)	Every clinic visit of the patient until 3 months
Secondary	Infection	Presence of infection symptoms as oozing or built up fluid around the affected area, bleeding, foul smell, overgrowth tissues around the edges of the toenail or abscess filled with puss.	Every clinic visit of the patient until 3 months
Secondary	Swelling	Presence of swelling symptoms as pain, redness and hardardening around the affected toenail.	Every clinic visit of the patient until 3 months
Secondary	Patient satisfaction	Patient satisfaction survey (0-10)	Every clinic visit of the patient until 3 months